The following content was featured in a recent Abstracts newsletter distributed by ASTCT. The Abstracts newsletter highlights the latest research in the clinical research and translational science studies aspects of transplantation and cellular therapy.
Guha A, Addison D, Jain P, et al. Cardiovascular Events Associated with Chimeric Antigen Receptor T Cell Therapy: Cross-Sectional FDA Adverse Events Reporting System Analysis. Transplantation and Cellular Therapy. 2021; 26 (12): 2211 (doi: 10.1016/j.bbmt.2020.08.036).
A large-scale study of adverse events (AEs) related to chimeric antigen receptor (CAR) T cell therapy found 19.7% were cardiovascular adverse events (CVEs), according to the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS). Researchers categorized CVEs as arrhythmias, heart failure (HF), myocardial infarction (MI), and other CVEs, and used logistic regression and hierarchical clustering to identify factors associated with CVEs. In all, 996 reported AEs were observed, with 39.1% associated with tisagenlecleucel and 60% with axicabtagene ciloleucel. The patients were age 54 years on average, and 38.9% were female. CVEs comprised 19.7% of all AEs reported to the FDA, with arrhythmia the most frequent (77.6%), followed by HF (14.3%) and MI (0.5%). An adjusted analysis found a positive correlation between patients presenting with CVE and neurotoxicity. Moreover, in patients presenting with both CVE and cytokine release syndrome (CRS), neurotoxicity was the most common noncardiac AE. The mortality rate among patients reporting CVE was 30.1%, while the mortality rate overall was 21.1%. Based on the findings, the researchers recommend that clinicians be alert for cardiovascular events if either CRS or neurotoxicity develops following CAR-T cell therapy.